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The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.

Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer.

The provided text is a 510(k) summary for the Bionx Implants Inc. Impact™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device, its intended use, and contraindications. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC/standalone).

Therefore, I cannot fulfill your request for that specific information based on the provided text.

The text does include:

• Device Name: Impact™ Suture Anchor
• Intended Use: To reattach soft tissue to bone in orthopedic surgical procedures, either arthroscopic or open. It stabilizes damaged soft tissue in conjunction with postoperative immobilization.
• Device Description: A bioabsorbable, screw-in (though later described as "push-in") suture anchor, preloaded with two non-absorbable #2 polyester sutures. Made from Self-Reinforced (96/4D) PLA Copolymer, 3.5mm diameter, 10.5mm length. Resorbs over several years, retains 90% strength for 20 weeks.
• Predicate Devices: Numerous Bionx Implants Inc., Arthrex Inc., Innovasive Devices, Inc., Instrument Makar, Inc., Linvatec Corporation, Mitek Surgical Products, Acufex Inc., and DePuy Inc. suture anchors.
• Material: Self-Reinforced (96/4D) PLA Copolymer, stated to be inert, non-collagenous, and non-pyrogenic. The poly-L/D-lactide material is the same as used in several previously cleared Bionx Implants Inc. devices.

Without the specific study information, I can only provide the structure of the requested table and indicate that the data is not available in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

For the remaining points, the information is not available in the provided text:

2. Sample size used for the test set and the data provenance: Not specified. The document does not describe specific performance testing with a test set of data/samples, but rather relies on substantial equivalence to predicate devices and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical medical implant, not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no external "ground truth" for performance is described in the context of a study. The substantial equivalence argument relies on material characteristics and predicate device equivalence.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established: Not applicable.

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The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer.

The provided text describes a 510(k) premarket notification for a medical device called the Duet™ Suture Anchor. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the requested information elements related to acceptance criteria, device performance, study design (test/training sets, ground truth, expert opinions, MRMC studies) are not explicitly described in the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document focuses on demonstrating that the Duet™ Suture Anchor has the "same intended use and principles of operation and very similar technological characteristics" as existing predicate devices. It states that "the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness." This implies that the device is expected to perform comparably to its predicates, but no specific performance metrics or acceptance criteria are listed for the Duet™ itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document is a 510(k) submission, not a clinical study report. It does not describe a test set or data provenance in the context of device performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth establishment is not discussed in the context of device performance in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication is not mentioned as no performance study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a bioabsorbable surgical anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable/Not provided. Ground truth is not discussed.

8. The sample size for the training set

• Not applicable/Not provided. Training sets are relevant for AI/machine learning models, which this device is not.

9. How the ground truth for the training set was established

• Not applicable/Not provided. Ground truth for a training set is not discussed.

Summary of what the document does provide:

• Intended Use: Reattachment of soft tissue to bone by arthroscopy or direct visualization.
• Predicate Devices: A long list of existing bioabsorbable suture anchors with similar intended uses and principles of operation.
• Material: Self-Reinforced (96/4D) PLA Copolymer, with the material provenance being previously cleared Bionx Implants Inc. devices.
• Mechanism of action: Retains 90% strength through 20 weeks and completely resorbs over several years, allowing gradual strength loss as collagen fibers heal.
• Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not raise new issues of safety or effectiveness. This is the primary "proof" of meeting regulatory requirements for this type of submission.

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The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

This 510(k) premarket notification for the SmartScrew™ bioabsorbable fixation rod does not contain the detailed information typically found in a clinical study report or a pre-market approval (PMA) submission regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through new clinical trials as would be required for a PMA. Therefore, most of the information requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not present.

The key points from this document relevant to your request are:

• Basis of Approval: The approval is based on a determination of substantial equivalence to previously cleared predicate devices (K952471, K974876, K992947, K003077). This means the FDA found the new device to be as safe and effective as the predicate devices, not that it met specific, predefined performance acceptance criteria from a new study.
• Similarities to Predicate Devices: The document explicitly states the new SmartScrew™ has the same indicated use, operating principle, basic design, dimensions, packaging, sterilization, shelf life, and trade name as the cleared SmartScrew (K003077). It further states that minor technological differences do not raise new issues of safety or effectiveness. This is the "proof" provided for a 510(k) – alignment with a device already deemed safe and effective.

Given this, I will answer the questions based on the absence of the requested information, which is characteristic of a 510(k) submission focused on substantial equivalence rather than new performance studies.

1. Table of acceptance criteria and the reported device performance

• Same indicated use
• Same operating principle
• Same basic design of threads
• Same basic dimensions
• Same packaging and sterilization methods
• Same shelf life
• Same trade name |

Note: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This often involves comparison of technological characteristics and performance data (e.g., mechanical testing, biocompatibility) if differences exist, but not necessarily against predefined clinical performance thresholds for a novel device.

2. Sample size used for the test set and the data provenance

Not applicable. This 510(k) submission does not describe a new clinical "test set" or a new clinical study with a sample size. The approval is based on substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) submission does not describe a new clinical study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This 510(k) submission does not describe a new clinical study involving a test set or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device (a bioabsorbable fixation implant) is a physical surgical implant, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical surgical implant, not an algorithm or AI device.

7. The type of ground truth used

Not applicable. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, manufacturing processes, and intended use, rather than through new clinical performance data that would require "ground truth" as typically understood in diagnostic or AI studies. The "ground truth" effectively comes from the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This 510(k) submission does not describe an AI/ML device or a training set.

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1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)

• Lengths of implants are 16, 18, 20 and 25 mm. -
• Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
• Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
• Shelf life is same with SmartNail™ -
• Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The provided document is a 510(k) summary for the "Bionx Implants Inc. 1.5mm Bone Fixation Kit." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically associated with a new device's efficacy or safety study.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The document aims to show that the new device is functionally the same as an already-approved device, thus not requiring new clinical performance studies.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not explicitly stated. This document is a 510(k) submission aiming for substantial equivalence. It does not present a de novo study with specific performance acceptance criteria or a "reported device performance" against those criteria in the way new drug or novel medical device clinical trials would. The "acceptance criteria" here implicitly relate to demonstrating similarity to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" or clinical data presented from a study to prove performance. The submission relies on technological characteristics and intended use equivalence to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set data or ground truth establishment by experts is described as this is a substantial equivalence claim.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set data requiring adjudication is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a bone fixation kit (a physical implant), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical bone implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The "ground truth" for this submission is the predicate device's pre-established safety and effectiveness. The new device aims to be substantially equivalent to that.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant to this physical medical device submission.

9. How the ground truth for the training set was established

• Not applicable.

Summary of Device Acceptance & Study Information from the Document:

The acceptance of the "1.5mm Bone Fixation Kit" into the market is based on its substantial equivalence to a predicate device, the "Bionx Implants Inc. SmartNail (K993074)." The "study" in this context is the detailed comparison of the new device's characteristics against the predicate device to support the claim of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as implied by Substantial Equivalence):

Data Provenance and Ground Truth:

• Data Provenance: The "data" proving equivalence comes from the specifications and characteristics of the new device and the known specifications and regulatory clearance of the predicate device (K993074). This is a descriptive comparison, not a clinical data collection.
• Ground Truth: The "ground truth" for the new device's safety and effectiveness is inferred from the established safety and effectiveness of the legally marketed predicate device.

Conclusion:

This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence, not a clinical trial report. As such, the concept of "acceptance criteria" and "study results" pertains to meeting the requirements for substantial equivalence by comparing the device features and intended use to a legally marketed predicate device, rather than presenting de novo clinical performance data.

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Properly used, in the presence of adequate immobilization, absorbable SmartNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. The SmartNail™ includes an arthroscopic applicator set. The arthroscopic applicator set consists of Handle, Tip, Piston, House, Wrench, Drill bit and K-wires.

The SmartNail™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of SmartNail™ upon the healing of growth plate has not been tested clinically.

The SmartNail™ is provided with a diameter of 1.5 mm and lengths of 16, 20 and 25 mm. 5 barbs, placed at intervals of 1.5 mm on two sides of the SmartNail™, prevent the implanted SmartNail™ from slipping out. The SmartNail™ is made of polylactide homopolymer and polylactide copolymer materials with strength retention time 20-50 weeks.

This 510(k) summary (K993074) for the Bionx Implants Inc. SmartNail™ does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.

The provided document is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical or analytical studies in the way an AI/ML device submission would.

Here's why the requested information is not present and what the document does provide:

• Type of Device: The SmartNail™ is an "Absorbable Bone Fixation Nail," a physical implant, not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic tool. Therefore, the usual metrics like sensitivity, specificity, AUC, or reader studies are not applicable.
• Purpose of 510(k): The primary goal of a 510(k) is to show that a new device is as safe and effective as a predicate device, as stated in the "Substantial Equivalence" section. This is typically achieved by comparing design, materials, manufacturing processes, intended use, and sometimes non-clinical performance data (e.g., mechanical strength, degradation properties) to the predicate.
• "Study that proves the device meets the acceptance criteria": For a physical implant like the SmartNail™, this would typically involve biocompatibility testing, mechanical testing (e.g., tensile strength, bending strength), and potentially animal studies or limited human clinical data to support safety and performance. However, these are generally presented as justification for substantial equivalence, not as a direct "performance study" with a defined acceptance criterion table in the summary. The summary mentions "strength retention time 20-50 weeks," which relates to performance, but no comparative data or acceptance criteria are provided in this specific document excerpt.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes, experts, adjudication, MRMC studies, or ground truth as these concepts are not addressed in this 510(k) summary for a physical implant.

The provided document details the following:

• Device Name: SmartNail™
• Submitter Information: Bionx Implants Inc.
• Date Prepared: September 2nd, 1999
• Classification Name: Bone Fixation Nail
• Product Code: IDS
• Predicate Devices:
  • Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902)
  • Bionx Implants Inc. SmartPin™ (K925098)
  • Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456)
  • Synthes Inc. Polypin (K961608)
• Intended Use: Fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodeses (e.g., apical fragments, osteochondral fragments, cancellous/non-load bearing fragments). Includes an arthroscopic applicator set.
• Contraindications: Fractures/osteotomies of cortical bone (except foot/hand), fractures/osteotomies in weight-bearing cancellous bone, situations where internal fixation is contraindicated (e.g., infection, patient non-cooperation), and physeal fractures in children.
• Device Description:
  • Diameter: 1.5 mm
  • Lengths: 16, 20, 25 mm
  • Features: 5 barbs placed at 1.5 mm intervals on two sides to prevent slipping.
  • Material: Polylactide homopolymer and polylactide copolymer materials.
  • Strength Retention Time: 20-50 weeks.
• Substantial Equivalence Rationale: Stated to be substantially equivalent to predicate devices due to same intended use, principles of operation, and very similar technological characteristics. Minor technological differences do not raise new safety or effectiveness issues.
• FDA Decision: The FDA found the device "substantially equivalent" and permitted it to be marketed (dated December 10, 1999).

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The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).

The SmartScrew ACL™ a fully threaded, cannulated interference screw with slightly tapered head and tip. SmartScrew ACL™ is provided with three different diameter, 7.0, 8.0 and 9.0mm and with three lengths, 20, 25 and 30mm and it is made of poly-L/D-lactide copolymer.

This document, K993073 for the SmartScrew ACL™, is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed studies proving specific acceptance criteria. Therefore, the requested information about acceptance criteria and detailed study results is largely not present within this document.

Here's what can be inferred and what is missing based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the 510(k) summary. The summary indicates that the SmartScrew ACL™ "has the same intended use, principles of operation and technological characteristics than predicate devices," implying that it is expected to perform similarly to those already approved devices. However, explicit acceptance criteria (e.g., specific tensile strength, degradation rates, biocompatibility metrics) and the SmartScrew ACL™'s performance against those criteria are not detailed.

2. Sample size used for the test set and the data provenance:

This information is not provided. 510(k) summaries for devices cleared based on substantial equivalence to predicates often do not include specific test set sizes or details about data provenance if no new clinical or performance studies were required. The focus is on comparing the new device's characteristics to the predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. This level of detail would typically be found in a detailed study report, which is not part of this 510(k) summary.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods are relevant for studies involving subjective assessments, usually in clinical trials, which are not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The SmartScrew ACL™ is a medical device (an interference screw for ligament reconstructions), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

This information is not explicitly stated. For a device like an interference screw, "ground truth" might refer to in-vitro biomechanical testing results (e.g., pull-out strength, stiffness), material characterization (e.g., degradation profiles), and biocompatibility testing. The summary mentions "minor technological differences... do not raise any new issues of safety or effectiveness," suggesting that standard testing (likely non-clinical) was performed to ensure safety and equivalence, but specific details about what this "ground truth" entailed are absent.

8. The sample size for the training set:

This information is not provided. This concept is typically relevant for machine learning algorithms, which is not the case for this device.

9. How the ground truth for the training set was established:

This information is not provided. Again, this concept is primarily relevant for machine learning algorithms.

In summary of the provided document (K993073):

The 510(k) summary for the SmartScrew ACL™ primarily relies on demonstrating substantial equivalence to existing predicate devices (Phantom PLLA Interference Screw, Resorbable Interference Screw, BioScrew Fixation System, etc.) rather than presenting detailed data from studies designed to prove specific acceptance criteria for the new device in isolation. The document states:

• "The SmartScrew ACL™ has the same intended use, principles of operation and technological characteristics than predicate devices."
• "Furthermore, the minor technological differences between the SmartScrew ACL™ and the predicate devices do not raise any new issues of safety or effectiveness."

This means that the "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to other devices already deemed safe and effective by the FDA. Specific performance metrics and study designs are not elaborated upon in this type of submission summary.

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The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Meniscus Arrow™ is as follows.

• Composed of poly-L/D-polylactide copolymer
• Length 10, 13 and 16mm
• Diameter 1.1mm
  The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).

The provided text is a 510(k) summary for the Bionx Implants Inc. Meniscus Arrow™ and an FDA clearance letter. It clearly states the device's intended use and describes its similarities to a predicate device, the Biofix® Biodegradable Meniscus Arrow System (K955768).

However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or specific details about training or test sets. Instead, the clearance for Meniscus Arrow™ is based on its substantial equivalence to the predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from the provided text. The document focuses on demonstrating that the new Meniscus Arrow™ is fundamentally the same as its already-cleared predecessor.

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